Left Atrial Mechanical Function Improvement After Atrial Fibrillation Catheter Ablation

Upstream-therapy by Telmisartan and Amlodipine Combination for Improvement of Left Atrial Mechanical Function After Pulmonary Vein Antrum Isolation

The objective of the study was to estimate the efficacy of telmisartan and amlodipine combination on the restoration of left atrial mechanical function after atrial fibrillation catheter ablation.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Drug: Telmisartan 80 mg and amlodipine 5 mg; Drug: Placebo (for telmisartan and amlodipine)

Detailed Description

64 candidates to atrial fibrillation ablation were included in the study. Patients were randomly assigned to telmisartan/amlodipine combination in dose 80/5 mg (group I, n=34) or placebo (group II, n=30) taking daily for up to one week. Echocardiography was performed before the procedure, immediately after it, and after a week of therapy. The six-minute walk test and SF-36 questionnaire results were evaluated a day before the procedure and after a week of the therapy. The left ventricular end-diastolic pressure was invasively measured after transseptal puncture and before left atrial sheath removal.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Symptomatic (III-IV class by European Heart Rhythm Association scale) paroxysmal atrial fibrillation;
• Ineffective therapy by at least one of the class I or III antiarrhythmic drugs;
• Left atrial diameter 5 cm or less;
• Estimated catheter radiofrequency pulmonary vein antrum isolation;
• Signed informed consent.

Exclusion Criteria:

• Intolerance/allergy or contraindications to telmisartan, amlodipine, warfarin or enoxaparin;
• Left atrial thrombosis;
• Age greater than 75 years;
• Severe (e.g. decompensation of vital functions) or acute (e.g. pneumonia) somatic conditions;
• Malignant growth in the hematogenic dissemination stage.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Therapy; Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days	Drug: Telmisartan 80 mg and amlodipine 5 mg; Other Names: Twynsta
Placebo Comparator: Placebo; Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days	Drug: Placebo (for telmisartan and amlodipine); Sugar pill manufactured to mimic telmisartan 80 mg and amlodipine 5 mg tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Passive Emptying of Left Atrium	Velocity time integral of transmitral flow during left ventricle early filling phase (VTI E, cm).	7 days
Active Emptying of Left Atrium	Velocity time integral of transmitral flow during atrial contraction (VTI A, cm).	7 days
Left Atrial Reservoir Function	Velocity time integral of transmitral flow (VTITMF, cm) during the whole diastole.	7 days
Diastolic Function	E/A ratio of transmitral flow	7 days
Isovolumic Relaxation	Left ventricular isovolumic relaxation time (IVRT, ms).	7 days
Pulmonary Vein Flow Emptying	S/D ratio of right superior pulmonary vein flow	7 days
Retrograde Flow in Pulmonary Veins	Velocity time integral of right superior pulmonary vein flow during left atrial systole (VTI Ar, cm)	7 days
Left Atrial Contractility	Left atrial active emptying fraction (LAAEF, %)	7 days
Left Atrial Dimensions	Left atrial antero-posterior diameter (LAD, cm)	7 days
Left Atrial Pressure Load	Mean left atrial pressure (MLAP, mm Hg).	7 days
Pulmonary Circulation Pressure Load	Right ventricular systolic pressure (RVSP, mm Hg).	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life	The average of eight scores of 36-Item Short Form Health Survey (SF-36). In every case all of eight scores (which ranges from 0 to 100) was summarized, then the sum was divided by 8. Thus the outcome also ranges from 0 (worse outcome) to 100 (better outcome).	7 days
Exercise Tolerance	six-minute walk distance in meters	7 days

Collaborators and Investigators

• Sponsor: Research Institute for Complex Problems of Cardiovascular Diseases, Russia
• Investigators: Study Chair: Yevgeny V Grigoriev, M.D., Ph.D., Research Institute for Complex Problems of Cardiovascular Diseases

Publications and helpful links

General Publications

• Mamchur S, Mamchur I, Khomenko E, Kokov A, Bokhan N, Sherbinina D. Mechanical function of left atrium and pulmonary vein sleeves before and after their antrum isolation. Medicina (Kaunas). 2014;50(6):353-9. doi: 10.1016/j.medici.2014.11.008. Epub 2014 Nov 28.

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: March 30, 2016
• First Submitted That Met QC Criteria: April 5, 2016
• First Posted (Estimate): April 12, 2016

Study Record Updates

• Last Update Posted (Actual): March 22, 2017
• Last Update Submitted That Met QC Criteria: February 1, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: atrial fibrillation; catheter ablation; contractility; left atrium; mechanical function
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Amlodipine; Telmisartan; Telmisartan amlodipine combination
• Other Study ID Numbers: 0546-2015-0013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO